ES2616478T3 - Reconstitution device with top cover - Google Patents

Abstract

A transfer arrangement comprising: a syringe (110), wherein said syringe (110) has a side wall defining a cavity (116), said syringe has first and second ends (111, 113) of the syringe, wherein said first end (111) of the syringe is open, a plunger (114) mounted within said syringe (110) to hermetically seal, thus, said first end (111) of the syringe, a needle (119 ) connected to said second end (113) of the syringe; a retaining stop (112) connected to said syringe, close to said first end (111) of the syringe; characterized in that it further comprises an adapter (124) having first and second ends (121, 123) of the adapter, wherein said first end (121) of the adapter is designed to be connected to said second end (113) of the syringe, said adapter extends around said needle (119) to prevent access to it, wherein said second end (123) of the adapter has a female luer connector (126); and a transfer member (128), wherein said transfer member (128) has first and second ends (131, 133) of the transfer member, wherein said first (131) end of the transfer member can be connected to said second end (123) of the adapter, wherein said second end (133) of the transfer member is arranged to receive a neck (130) of a vial.

Description

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DESCRIPTION

Reconstitution device with top cover Field of the invention

The present invention relates to a reconstitution system and, more particularly, it relates to a reconstitution system using a syringe.

Background of the invention

Typically, a syringe is filled manually by suctioning a liquid pharmaceutical component from a pharmaceutical vial having a penetrable closure. The syringe has a needle that penetrates the penetrable closure, after which the syringe is typically filled by sucking air into the syringe body, aligning the needle with the penetrable closure of the vial and inserting the needle through the penetrable closure in the vial Subsequently, the vial is inverted and the air is forced to pass from the syringe body to the vial body. Next, the embolus is removed to extract the desired volume of the pharmaceutical component into the syringe and the needle is removed from the vial.

The reconstitution indicated above is performed because many pharmaceutical preparations must be distributed and marketed as two separate components, typically a solid component and a liquid component. These are mixed just before administration. In reality, each of the two or more components can be liquid.

Typically, many procedures require that the needle be removed from the syringe, because there is a danger of contamination of the needle. In addition, the silicone in the needle can be removed during penetration into the vial.

Document US20060184103 describes a transfer arrangement that includes all the technical features of the preamble of claim 1.

Summary of the invention

An object of the present invention is to provide a set for transferring the contents of the first container to a second container without contamination or alteration of the needle.

According to one aspect of the present invention, a transfer arrangement is provided as claimed in claim 1 comprising a syringe, wherein the syringe has a side wall defining a cavity, the syringe has first and second ends of the syringe. , in which the first end of the syringe is open, a plunger mounted inside the syringe to thereby seal the first end of the syringe, a needle connected to the second end of the syringe, an adapter having first and second ends of the adapter, in which the first end of the adapter is designed to connect to the second end of the syringe, in which the adapter extends around the needle to prevent access to it, in which the second end of the adapter has a luer connector, and a transfer member, in which the transfer member has first and second ends of the transfer member, in which the first end of the member of Transfer is connectable to the second end of the adapter, in which the second end of the transfer member is arranged to receive a neck of a vial.

The syringe used in the present invention may be of the conventional type. In this way, the syringe has a first end with a needle located therein, with a second end open. There is a plunger mounted inside the syringe to contain the material in it, in a conventional manner. The needle can be of the fixed type, that is, permanently fixed to the end and in communication with the inside of the syringe.

The transfer arrangement also includes an adapter with a first end of the adapter designed to connect to the end of the syringe that has the needle. The adapter extends around the needle to prevent access to it. This is a safety measure to prevent accidental punctures. The opposite end of the adapter preferably has a luer connection.

When not being used, the transfer device also preferably includes an upper cover, which fits inside the end of the adapter that has the luer connector.

The transfer arrangement also includes a transfer member having first and second ends of the transfer member, in which the first end of the transfer member is connectable to the end of the adapter after removal of the top cover, in which the The second end of the transfer member is designed to receive the neck of a vial.

As used in the mayonnaise of the syringe arrangements, a plunger rod is provided that is connectable to the plunger. For operational purposes, preferably a rear stopper connected to the syringe is also provided,

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next to the first syringe to help in the movement of the plunger rod.

Brief description of the drawings

After describing the invention in this way in general, reference will be made to the accompanying drawings illustrating an embodiment thereof, in which:

Figure 1 is a side elevational view of a transfer device according to the present invention;

Figure 2 is a side elevational view, partially in section, of a vial containing a medicament;

Figure 3 is a side elevational view of a syringe and a plunger rod;

Figure 4 is a cross-sectional view of the transfer device before use;

Figure 5 is a side sectional view of the device being placed in a vial;

Figure 6 is a side sectional view showing the perforation of the vial;

Figure 7 is a cross-sectional view illustrating the cover being removed;

Figure 8 is a cross-sectional view illustrating a luer-type syringe prepared to be placed in the vial;

Figure 9 is a view, partially in cross section, of a syringe with luer-type blockage that is being fixed to the transfer device;

Figure 10 is a sectional view illustrating the mixing of the components;

Figure 11 is a sectional view illustrating the suction of the mixture into the syringe;

Figure 12 is a sectional view showing the syringe that is being disconnected;

Figure 13 is a cross-sectional view illustrating the placement of the transfer assembly in a vial;

Figure 14 is a detailed view illustrating the transfer assembly and the vial before the vial is inserted;

Figure 15A is a bottom perspective view of a transfer assembly according to an embodiment of the present invention;

Figure 15B is a bottom plan view thereof;

Figure 16A is a perspective view of the transfer assembly according to a further embodiment;

Figure 16B is a bottom plan view thereof;

Figure 17A is an exploded view of the transfer assembly;

Figure 17B is a bottom perspective view thereof;

Figures 17C to 17E show the sequence of placement of the transfer assembly in the vial;

Figures 17F to 17H illustrate the placement of the transfer assembly in a further embodiment thereof in a vial;

Figure 18 is a detailed view of the transfer assembly; Y

Figures 19A to 19D are perspective views illustrating the placement of the transfer assembly in a vial and its removal.

Figure 20 is a view of a fixed needle syringe using the concept of the present invention; and Figures 21 to 28 illustrate the use of the system of the present invention.

Detailed description of the invention

With more detailed reference to the drawings and with reference characters therein, a transfer system generally designated by the reference number 10 and which is suitable for use with a vial generally designated by the reference number 12 is illustrated.

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The vial 12 has a body 14 with a neck sealed by a partition 16 on which there is a lid 18. A medicament 20 is contained within the body 14 and would typically comprise a dry ingredient, although a fluid can also be used.

The transfer system 10 includes an outer housing 24 and a circular side wall 26. In the circular side wall 26, there is a protuberance 28 near the bottom thereof. At its upper end, a 30 luer connection is provided. An inner wall 32 receives or has a needle 34 that is hollow and has a piercing end 36. As indicated above, the needle 34 may be a point or punch.

Internally mounted to the outer housing 24, there is a mobile member 40. The mobile member 40 has an upper wall 42 with an opening 44 located in the center thereof to allow the passage of the needle 34. Extending downwardly from the upper wall 42, there is a first leg 46 and a second leg 48. The First leg 46 has a flange 50 that extends outwardly in its lower part, while the second leg 48 also has a flange 52 that extends outwardly.

A cover 56 is provided to receive the transfer system 10. The cover 56 has a side wall 57 that is adapted to engage the boss 28 to retain the transfer system 10 in position. The side wall 57 is provided with a flange 60 that extends outwardly at the bottom thereof. The flange 60 is designed to receive a removable seal strip 62 to provide a tightly sealed container.

Preferably, a transfer system is used with a syringe having a syringe body 66 and a plunger 68 mounted thereon. A plunger rod 70 is designed to be threadablely coupled with the plunger 68. The syringe body 66 includes a retaining stop 72 to allow a proper grip by a user's hand. At its front end, the syringe body 68 includes a 74 luer connector. Typically, the syringe body 66 is filled with a diluent 76, although any desired fluid can be used.

As shown in Figures 8 and 9, the plunger rod 70 is connected to the plunger 68 and the diluent 76 is then forced into the body 14 of the vial, as shown in Figure 10. Next, the medication and diluent can be mixed and the assembly can be inverted, as shown in Figure 11. Next, the mixture 80 is sucked back into the body 66 of the syringe. Next, the mixture 80 is ready for injection when a needle assembly is connected to the 74 luer connector.

In the embodiment of Figures 17A to 17H, it will be noted that the outer housing 24 is provided with a pair of openings 86 in the side wall 26. Also, in this embodiment, there are provided a pair 87 of additional legs, each of which has buttons 88 formed on an outer surface thereof. In this embodiment, when the mobile member 40 moves upward, the buttons 88 engage in the openings 86.

On the inner surface of the wall 26, ribs 90 are provided having a groove 92 formed therein. Thus, when pressure is exerted on the buttons 86 as the vial 12 is being removed, the movable member 40 is moved downward until the upper wall 42 engages with the groove 92. This retains the movable member 40 in its position for later use.

In the embodiment of Figures 18 to 19D, it will be noted that the upper wall 42 is provided with protrusions 96 and interlocking couplings 98. Inside, ribs 100 and angled side wall portions 102 are provided. The arrangement is such that after an upward movement of the mobile element 94, the protrusions 96 are coupled with the angled side wall 102 to rotate the mobile member 40. After removal, the interlocking couplings 98 are coupled with the rib 100 in order to prevent further use of the transfer element.

As shown in Figure 20, the present invention uses a syringe generally designated by reference number 110. Syringe 110 is provided with a retaining stop 112, as is known in the art. A plunger 114 seals a first end 111 of the syringe and defines a compartment 116 that will contain the liquid diluent. A plunger rod 118 is used to advance the plunger 114, when necessary.

At the second end that forms the injection end 113, a fixed needle 119 and a needle guard 120 are provided. An upper cover 122 extends over the needle 119.

An adapter generally designated by reference number 124 has first and second ends 121, 123, respectively, with an internal 126 luer connector located at the second end 123 of the adapter.

During operation, and as shown in Figures 21 to 28, a transfer member 128 is provided, as described above in Figures 1 to 19, and having first and second ends 131 and 133 of the member of transfer. A vial 130 contains the dry component 135 to be mixed with the liquid in the compartment 116 of the syringe 110.

Initially, the transfer system 128 is placed on top of the vial 130, as shown in the

Figure 22. Subsequently, the top cover 122 is removed. As seen in Figure 24, the transfer system 128 is then connected by the luer connector to the syringe 110. As shown in Figure 25, the reconstitution is then initiated with an initial downward movement to transfer the liquid inside the vial 130 and the subsequent suction to bring the mixture back into the syringe 110.

5 Subsequently, as shown in Figure 26, the vial and transfer system 128 are disconnected and then, as shown in Figure 28, syringe 110 is prepared for injection of its contents.

Using the previous system, the needle used for injection is protected at all times. In this way, there is no risk of damaging the needle 119 nor is there a possibility of contaminants entering the system.

It will be understood that the embodiment described above is for illustrative purposes only and that changes and modifications may be made thereto. In this way, other vial adapters could be used and the use of a cap is not necessary.

Claims (12)

5 10 fifteen twenty 25 30 35 40 Four. Five 1. A transfer provision comprising: a syringe (110), wherein said syringe (110) has a side wall defining a cavity (116), said syringe has first and second ends (111, 113) of the syringe, wherein said first end ( 111) of the syringe is open, a plunger (114) mounted inside said syringe (110) to hermetically seal, in this way, said first end (111) of the syringe, a needle (119) connected to said second end ( 113) of the syringe; a retaining stop (112) connected to said syringe, close to said first end (111) of the syringe; characterized in that it further comprises an adapter (124) having first and second ends (121, 123) of the adapter, wherein said first end (121) of the adapter is designed to connect to said second end (113) of the syringe, said adapter extends around said needle (119) to prevent access to it, wherein said second end (123) of the adapter has a female luer connector (126); Y a transfer member (128), wherein said transfer member (128) has first and second ends (131, 133) of the transfer member, wherein said first (131) end of the transfer member can be connected to said second end (123) of the adapter, wherein said second end (133) of the transfer member is arranged to receive a neck (130) of a vial. 2. Transfer arrangement according to claim 1, which further includes a plunger rod (118) connected to said plunger (114). 3. Transfer arrangement according to claim 1, further including a vial (130), wherein said vial (130) is connected to said second end (133) of the transfer member. 4. Transfer arrangement according to claim 3, wherein said needle (119) is a fixed needle. 5. Transfer arrangement according to claim 3, wherein said vial contains a medicament (135) and said syringe therefore contains a diluent. 6. Transfer arrangement according to claim 1, wherein said transfer device comprises: a housing (24) having an upper part, a lateral wall (26), an open lower part, in which said open lower part allows the insertion of a vial (12) into said housing; a piercing member (34) mounted within said housing (24), wherein said piercing element (34) has a piercing tip (36) located at a lower end thereof, wherein said piercing member has an inner duct formed therein; a connector (30) located on an outer side of said upper part; a mobile member (40) mounted inside said housing (24), wherein said mobile member (40) is mobile from a first position in which said mobile element (40) prevents access to said piercing tip (36) and a second position that allows access to said piercing tip when said vial is inserted into said housing. 7. Transfer device according to claim 6, wherein said mobile member (40) and said housing (24) cause said mobile member (40) to rotate when said mobile element (40) moves upward after insertion of said vial (12), wherein said movable member returns to a third blocking position after removal of said vial, wherein said third blocking position is such that an additional vial cannot be inserted into said housing. 8. Transfer device according to claim 6, wherein said mobile member includes at least one leg (46), wherein said housing has a recess formed therein, wherein said leg is coupled to said recess when said mobile member is in said second position, in which said mobile member can return to said first position after the withdrawal of said vial by pressing on said leg to release said leg from said recess. 9. Device according to claim 7, wherein said piercing member (34) is selected from the group consisting of a needle or a point or punch. 10. Device according to claim 9, wherein said mobile member (40) has an opening (44) located in the center to allow said piercing member (34) to pass through it. 11. Device according to claim 7, wherein said connector (30) on the outer side of said upper part comprises a luer connector. 12. Device according to claim 8, wherein said mobile member (40) has two projections, wherein each projection is located on a leg between the respective diametrically opposite legs. 5 13. Device according to claim 12, wherein said housing (24) has a recess formed on a inner surface thereof to receive a disk part of said mobile member (40) when said mobile member is in said first position.